Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard

Abstract

Abstract: AbstractsInternational Organization for Standardization(ISO) recently released "Invitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The new standard revised the system accuracy and the consensus network error(CEG) and the user performance evaluation, and increased the hematocrit and the interfering substances etc. This article discussed the foundation of the ISO15197 2013 standard, and analysed the difference of the new and revised technical indicators.

Key words: blood glucose monitoring systems, the system accuracy

CLC Number:

R197.39

WU Chuan-song DONG Jin-chun. Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard[J]. Chinese Journal of Pharmacovigilance, 2014, 11(3): 144-146.

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